Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz® (adalimumab) for use in all indications of the reference medicine***, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis and ulcerative colitis.
Rheumatoid arthritis alone affects up to 1% of people in the European Union. Patients with moderate to severe rheumatoid arthritis can have chronic inflammation that causes fatigue, pain and joint stiffness. Symptoms can be reversible with appropriate treatment, however the joint damage and the resulting disability are permanent. The introduction of biosimilars has been shown to improve access to advanced treatment options, such as biologic medicines.
“We believe in making access happen for patients who are suffering from chronic inflammatory diseases. Earlier and expanded access to important, disease-modifying, biologic medicines can fundamentally change how patients manage their health,” said Stefan Hendriks, Global Head of Biopharmaceuticals, Sandoz. “Biosimilars such as Hyrimoz can also play a transformational role in healthcare system sustainability – so we look forward to making Hyrimoz, and other important biosimilar medicines, broadly available.”
The approval was based on a comprehensive data package comprising analytical, preclinical and clinical research demonstrating that Hyrimoz matches the reference biologic in terms of safety, efficacy and technical quality. A randomized, double-blind, three-arm, parallel study confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters. A Phase III confirmatory safety and efficacy study (ADACCESS) demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic. No meaningful clinical differences were observed.
Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Hyrimoz is the company’s seventh approved biosimilar medicine in Europe. Additional biosimilars for oncology and immunology indications are expected to launch globally across major regions by 2020.